Driving sustainable clinical research

The pandemic imprinted a sense of purpose, urgency, and collaboration across the life sciences industry. With millions of lives and economic stability at stake, stakeholders across pharma, technology companies, and regulatory agencies proved that sling-shotting Drug Development from years to months when it matters the most is feasible. We need to take the scientific learnings of 2020 and accelerate them with robust engineering. The post-pandemic world will not accept the traditional missteps and realignments of pre-pandemic era drug development.

A new category of purpose-built and intelligent infrastructure needs to emerge to bring a sustainable transformation for drug development. We call it “Intelligent Clinical Cloud,” a clinical insights platform for achieving scale, acceleration, and repeatability across therapeutic areas. Here are some specific capabilities that these new category players should provide:

• Smart Research
  
  Sharing clinical insights is even more important than just sharing clinical data. Technical building blocks, such as provisions for IP protection and monetization, are necessary to enable the free flow of clinical research information across studies and pharmaceutical companies for error-free, accelerated drug development. Smart Research will provide the reference framework and tools for sharing curated clinical insights.
• Smart Apps
  
  A new class of clinically trained Smart Apps will transform clinical operations, data management, statistical computing, regulatory submission, and other areas which have typically caused drug development delays. Context-aware with humans in the loop, these Smart Apps will be trained and curated by experts with real clinical data for automation and speed. They will exchange insights across clinical processes and studies in a continuous learning mode. Clinical studies will no longer need to start from scratch; instead, they will be enabled by Smart Apps that deliver insights and the ever-expanding network effects of integrated knowledge.
• Smart Ops
  
  Traditional IT Infrastructure management and DevOps will become clinical-aware with clinical and operational data, to scale and automate complex tasks around onboarding, processing, and curating study data pipelines. We will see ‘contextual AI’ from Smart Apps seamlessly manage and scale IT infrastructure, based on the specific clinical study’s ambient environment and use case. For example, by predicting resource spikes in advance, time can be saved by pre-ordering capacity.
• Smart Outcomes
  
  Traditional clinical workflows and processes will be integrated with outputs from AI models to deliver Smart Outcomes. Tools to meter and measure business outcomes from Smart Apps will emerge, opening up the path for a new generation of pricing models based on accelerated efficiency gains. Sponsors will be billed based on outcomes delivered by the intelligent clinical cloud, not the consumption of technology.

During the last 10 months of rapid vaccine development, a few innovative pharma companies have dramatically advanced the way clinical research is conducted. A robust engineering platform is needed to sustain and scale those advances: Intelligent Clinical Cloud will be that enabler.

Note: A part of this article was previously published in PharmaVOICE’s inaugural Trend Tracking feature, in January 2021.